NCT04086472

Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)

A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Participants Inoculated With Experimental Respiratory Syncytial Virus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine if a single intravenous (IV) dose of clesrovimab when administered at 1 of 4 dose levels results in a reduction in viral load after intranasal inoculation (with RSV A Memphis 37b) compared to IV placebo. It is hypothesized that at least 1 of the 4 dose levels of clesrovimab given prior to inoculation will reduce the area under the viral load-time curve (VL-AUC) from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40) compared to placebo.

Conditions

• Respiratory Syncytial Viruses

Interventions

Type	Name	Description
BIOLOGICAL	Clesrovimab	Single dose of clesrovimab administered via IV infusion.
OTHER	Placebo	Placebo (0.9% sodium chloride, USP sterile saline) administered via IV infusion.
BIOLOGICAL	RSV-A Memphis 37b	Approximately 4Log10 plaque-forming units (PFU)/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.

Timeline

• Start date: 2019-10-28
• Primary completion: 2020-03-22
• Completion: 2020-08-14
• First posted: 2019-09-11
• Last updated: 2022-09-14
• Results posted: 2021-04-13

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study